Language Development DisordersNCT05921214
The Effect of Semantic Support on Word Learning
A study testing VAULT Phase 5 in people with Language Development Disorders, run by University of Arizona at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare word learning outcomes in late talking toddlers who are taught different types of words. The main question it aims to answer is if teaching words that come from categories that children already know (e.g., animals) will aid overall word learning. Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Language Development Disorders
- What is being tested?
- VAULT Phase 5
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Native English Speaking
- Pass pure tone hearing screening or medical report of normal hearing
- 2-3 Years of age
- MCDI expressive scale <10th percentile
Who cannot join
- Parental report of other diagnoses
- Enrolled in concurrent treatment elsewhere
- Nonverbal IQ <75 as measured by the Bayley scales
- Parents unable to consistently bring child to treatment sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arizona
Tucson, Arizona, 85721
Nora Evans-Reitz, M.S., 520-626-6885, nevansreitz@arizona.edu
Cecilia Figueroa, M.S., 520-626-6885, cecilm@arizona.edu
About this study
Official title: Identification of Treatment Parameters That Maximize Language Treatment Efficacy For Children
The goal of this clinical trial is to compare word learning outcomes in late talking toddlers who are taught different types of words. The main question it aims to answer is if teaching words that come from categories that children already know (e.g., animals) will aid overall word learning. Children will take part in the Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment and be taught words from more familiar or less familiar categories to see which group learns more words overall.
Read the detailed description
Children will be assigned to either the familiar or less-familiar word group. All children will receive 8 weeks of Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment (2x/wk for 30 minutes each session). The investigators will measure how well children learn the words they are taught as well as the words that are in the environment, but not explicitly taught (control words). This will help us know if their learning is due to treatment or maturation. The investigators will compare children to themselves (taught words v. control words) to ensure that the overall treatment is working. Then, the investigators will compare children in the familiar word group to children in the less-familiar word group to see which group learns more overall.
- Conditions
- Language Development Disorders
- Being tested
- VAULT Phase 5
- Keywords
- Late Talkers
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAULT Phase 5Behavioural
This is an input-based vocabulary learning treatment based on principles of statistical learning.
| Study group | Role | What they receive |
|---|---|---|
| Familiar Words | Experimental | In this condition, children will learn new words that come from semantic categories (e.g., animals, body parts) from which they currently understand at least several words. Receives: Behavioral: VAULT Phase 5 |
| Less-Familiar Words | Active comparator | In this condition, children will learn new words that come from semantic categories (e.g., animals, body parts) from which they currently understand few or no words. Receives: Behavioral: VAULT Phase 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Effect Size
The investigators will count the number of spontaneous and probed productions of target and control words and calculate a treatment effect size (d).
Measured: Change from baseline through treatment, which will average an 8-week time frame.
Number/Rate of Words Learned
The investigators will measure the number of words learned and rate of words learned as reported by the parent on the MCDI starting prior to treatment, and measured during, immediately following, and 4-6 weeks after treatment.
Measured: Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.
Secondary outcomes (1)
Post Treatment Retention
The investigators will use probe data and parental report to determine how many words the child retained from treatment.
Measured: Change from end of treatment to follow up, which will average 4-6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start10 Jun 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language Development DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using treatment effect sizes, children will be compared to themselves (treatment words v. control words) and across groups (familiar word group v. less-familiar word group).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Mary Alt, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921214
- Sponsor's protocol ID
- Late Talker Phase 5
- Other IDs
- 2R01DC015642-06
- Status last verified
- Jul 2026
- First submitted
- 14 Jun 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Treatment Parameters That Maximize Language Treatment Efficacy For Children
- ClinicalTrials.gov ID
- NCT05921214
- Acronym / sponsor ID
- Late Talker Phase 5
- Conditions
- Language Development Disorders
- Keywords
- Late Talkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare word learning outcomes in late talking toddlers who are taught different types of words. The main question it aims to answer is if teaching words that come from categories that children already know (e.g., animals) will aid overall word learning. Children will take part in the Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment and be taught words from more familiar or less familiar categories to see which group learns more words overall.
Detailed description
Children will be assigned to either the familiar or less-familiar word group. All children will receive 8 weeks of Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment (2x/wk for 30 minutes each session). The investigators will measure how well children learn the words they are taught as well as the words that are in the environment, but not explicitly taught (control words). This will help us know if their learning is due to treatment or maturation. The investigators will compare children to themselves (taught words v. control words) to ensure that the overall treatment is working. Then, the investigators will compare children in the familiar word group to children in the less-familiar word group to see which group learns more overall.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Using treatment effect sizes, children will be compared to themselves (treatment words v. control words) and across groups (familiar word group v. less-familiar word group).
| Arm | Type | Receives |
|---|---|---|
| Familiar Words | Experimental | Behavioral: VAULT Phase 5In this condition, children will learn new words that come from semantic categories (e.g., animals, body parts) from which they currently understand at least several words. |
| Less-Familiar Words | Active comparator | Behavioral: VAULT Phase 5In this condition, children will learn new words that come from semantic categories (e.g., animals, body parts) from which they currently understand few or no words. |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Native English Speaking
- Pass pure tone hearing screening or medical report of normal hearing
- 2-3 Years of age
- MCDI expressive scale <10th percentile
Key exclusion criteria (4 listed)
- Parental report of other diagnoses
- Enrolled in concurrent treatment elsewhere
- Nonverbal IQ <75 as measured by the Bayley scales
- Parents unable to consistently bring child to treatment sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAULT Phase 5This is an input-based vocabulary learning treatment based on principles of statistical learning. | Behavioural | Familiar Words, Less-Familiar Words |
Primary outcome
Treatment Effect Size
Time frame: Change from baseline through treatment, which will average an 8-week time frame.
The investigators will count the number of spontaneous and probed productions of target and control words and calculate a treatment effect size (d).
Number/Rate of Words Learned
Time frame: Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.
The investigators will measure the number of words learned and rate of words learned as reported by the parent on the MCDI starting prior to treatment, and measured during, immediately following, and 4-6 weeks after treatment.
1 secondary outcome
Post Treatment Retention
Time frame: Change from end of treatment to follow up, which will average 4-6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Alt, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAULT Phase 5 in people with Language Development Disorders, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Alt, PhD (520-626-6180, malt@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Effect Size (time frame: Change from baseline through treatment, which will average an 8-week time frame.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.